Sep

2016

Siemens RAPIDPoint 405 Cl II

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report 9/21/2016
Class lI:

PRODUCT

Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
Recall Number Z-2798-2016

REASON
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system

RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Norwood, MA on 9/14 2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2910 units

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Siemens RAPIDPoint 405 Cl II

Amy Sellers

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